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Study of Oral Anthocyanins on Insulin Resistance

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by University of Aberdeen
Sponsor:
Information provided by (Responsible Party):
University of Aberdeen
ClinicalTrials.gov Identifier:
NCT01180712
First received: August 11, 2010
Last updated: November 17, 2014
Last verified: November 2014

August 11, 2010
November 17, 2014
June 2010
September 2015   (final data collection date for primary outcome measure)
Oral Glucose Tolerance Test [ Time Frame: Day 0 and 21 days post intervention ] [ Designated as safety issue: No ]
Change in Oral Glucose Tolerance following intervention
Oral Glucose Tolerance Test [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
Change in Oral Glucose Tolerance following intervention
Complete list of historical versions of study NCT01180712 on ClinicalTrials.gov Archive Site
  • Fasting blood glucose/insulin [ Time Frame: Day 0, 7, 14, and 21 days post intervention ] [ Designated as safety issue: No ]
    Change in fasting blood glucose/insulin in response to intervention
  • Adipose tissue gene expression [ Time Frame: Day 0 and 21 days post intervention ] [ Designated as safety issue: No ]
    Change in inflammatory gene expression in sub C adipose tissue biopsies following intervention
  • Fasting blood glucose/insulin [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    Change in fasting blood glucose/insulin in response to intervention
  • Adipose tissue gene expression [ Time Frame: one hour ] [ Designated as safety issue: No ]
    Change in inflammatory gene expression in sub C adipose tissue biopsies following intervention
Not Provided
Not Provided
 
Study of Oral Anthocyanins on Insulin Resistance
Study of Oral Anthocyanins on Insulin Resistance

Dietary strategies for alleviating the metabolic complications such as diabetes associated with obesity are actively being pursued as alternatives to pharmaceutical interventions The genus Vaccinium (e.g. blueberry, blaeberry, cranberry) has been used traditionally as a source of folk remedies for established diabetic symptoms, primarily as leaf or stem infusions or decoctions. Berries from this family such as blaeberry (BL) and blueberry (BB) are enriched in anthocyanins, polyphenolics recognized for their ability to provide and activate cellular antioxidant protection, inhibit inflammatory gene expression, and consequently protect against oxidant-induced and inflammatory cell damage and cytotoxicity. The association of obesity with adipose tissue stress, macrophage recruitment, and inflammatory gene expression suggests that eating edible berries from this genus might provide an effective alternative or supplementary intervention to attenuate obesity- associated inflammation and the associated insulin resistance.

The aim of this study is to determine the effects of anthocyanin supplementation in the form of a concentrated blaeberry extract on insulin resistance and inflammation particularly in the adipose tissue following a three week supplementation period.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes
Dietary Supplement: Mirtoselect

Male subjects (BMI > 30) with type 2 diabetes controlling their diabetes by diet alone or impaired glucose tolerance.

Volunteers will be given either a total daily dose of 1.4 grams of concentrated blaeberry extract (mirtoselect provided by Indena S.p.A. (http://www.mirtoselect.info/) in a hard gelatin capsules or control capsules containing lactose administered thrice a day for 21 days.

  • Active Comparator: Blaeberry concentrated caspule

    30 obese male subjects (BMI > 30) with type 2 diabetes controlling their diabetes by diet alone or impaired glucose tolerance.

    Volunteers will be given a total daily dose of 1.4 grams of mirtoselect (a concentrated blaeberry extract) a day formulated in hard gelatin capsules (0.47 gram per capsule) administered thrice a day for 21 days.

    Mirtoselect provided by Indena S.p.A. (http://www.mirtoselect.info/)

    Intervention: Dietary Supplement: Mirtoselect
  • Placebo Comparator: Placebo capsules containing lactose

    30 obese male subjects (BMI > 30) with type 2 diabetes controlling their diabetes by diet alone or impaired glucose tolerance.

    Volunteers will be given a placebo consisting of lactose formulated in hard gelatin capsules administered thrice a day for 21 days.

    Intervention: Dietary Supplement: Mirtoselect

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
September 2015
September 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Obese male subjects (BMI > 30)
  • Aged > 40 and < 70 years of age
  • Type 2 diabetes; subjects controlling their diabetes by diet alone or with impaired glucose tolerance
  • All the obese subjects will have a waist circumference over 40 inches
  • All subjects must live the Aberdeenshire area of Scotland

Exclusion Criteria:

Medical exclusion criteria:

  • Chronic illness, including:

    • thromboembolic or coagulation disease,
    • unregulated thyroid disease,
    • kidney disease,
    • hepatic disease,
    • severe gastrointestinal disorders,
    • pulmonary disease (e.g. chronic bronchitis, COPD),
  • Alcohol or any other substance abuse,
  • Eating disorders,
  • Psychiatric disorders (including severe depression, lithium treatment, schizophrenia, severe behavioural disorders),
  • Skin conditions on the abdomen,
  • Allergy to skin dressings,

Medication exclusion criteria:

  • Oral steroids,
  • Tricyclic antidepressants, neuroleptics,
  • Anticoagulants,
  • Digoxin and antiarrhythmics,
  • Chronic use of antiinflammatories (e.g. high doses of aspirin, ibuprofen),
  • Insulin, Sulphonylureas, Thiazolidinediones (glitazones), metformin
Male
40 Years to 70 Years
No
Contact: Nigel Hoggard, PhD 01224 716655 n.hoggard@abdn.ac.uk
United Kingdom
 
NCT01180712
REC 10/S0802/27, Rowett 901
Yes
University of Aberdeen
University of Aberdeen
Not Provided
Principal Investigator: Nigel Hoggard, PhD University of Aberdeen Rowett Institute of Nutrition and Health
University of Aberdeen
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP